Quetiapine Fumarate

Product NDC: 72865-267
Requested package NDC: 72865-267-01
11-digit product format: 728650267
Labeler code: 72865
Product ID: 72865-267_4dc52dc1-ab22-a157-e063-6394a90a9d23
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Quetiapine Fumarate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: XLCare Pharmaceuticals Inc.
Application: ANDA204316
Marketing category: ANDA
Marketing start: 2024-02-02
Substance: QUETIAPINE FUMARATE
Active strength: 200 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204316-001	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16
A204316-002	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16
A204316-003	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16
A204316-004	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16
A204316-005	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16
A204316-006	QUETIAPINE FUMARATE	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A204316-001	AB
A204316-002	AB
A204316-003	AB
A204316-004	AB
A204316-005	AB
A204316-006	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-005	QUETIAPINE FUMARATE	EQ 300MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-006	QUETIAPINE FUMARATE	EQ 400MG BASE	TABLET / ORAL	AB	2022-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-001	QUETIAPINE FUMARATE	EQ 25MG BASE	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-002	QUETIAPINE FUMARATE	EQ 50MG BASE	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-003	QUETIAPINE FUMARATE	EQ 100MG BASE	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-004	QUETIAPINE FUMARATE	EQ 200MG BASE	TABLET / ORAL	AB	2022-06-16	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204316-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204316-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204316-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204316-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204316-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204316-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204316-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204316-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204316-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204316-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204316-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204316-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204316-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204316-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204316-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204316-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204316-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204316-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204316-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Quetiapine Fumarate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
QUETIAPINE FUMARATE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2S3PL1B6UJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312743	Internal RxNorm lookup
312744	Internal RxNorm lookup
312745	Internal RxNorm lookup
317174	Internal RxNorm lookup
616483	Internal RxNorm lookup
616487	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
070faf07-0ce7-4354-8643-9d222b72ecad	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ef42f82-f087-0d2c-105f-f791ca69210e	Product name	8	20250729
21205abd-8c89-4943-9f85-908f3d4fc3bb	Product name	5	20230501

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72865-267-01	Quetiapine Fumarate	100 in 1 BOTTLE	TABLET, FILM COATED	100	3
72865-267-05	Quetiapine Fumarate	500 in 1 BOTTLE	TABLET, FILM COATED	500	3
72865-267-90	Quetiapine Fumarate	90 in 1 BOTTLE	TABLET, FILM COATED	90	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72865-267	QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [XLCARE PHARMACEUTICALS INC.]	2	Current NDC, 3 package rows	20250328_070faf07-0ce7-4354-8643-9d222b72ecad.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	3085f68d-e83c-4f59-b058-8bdae7f4e537	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204316 application number: ANDA204316
Quetiapine Fumarate	QUETIAPINE FUMARATE	REMEDYREPACK INC.	b8864cb9-1c6a-4e36-9893-eb1403ee8745	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204316 application number: ANDA204316
Quetiapine Fumarate	QUETIAPINE FUMARATE	XLCare Pharmaceuticals Inc.	070faf07-0ce7-4354-8643-9d222b72ecad	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204316 application number: ANDA204316 ndc (package): 72865-267-01 ndc (product): 72865-267 ndc11 (package): 72865026701
Quetiapine Fumarate	QUETIAPINE FUMARATE	ST. MARY'S MEDICAL PARK PHARMACY	3624c430-2a17-a83a-e063-6394a90add93	2025-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204316 application number: ANDA204316
Quetiapine Fumarate	QUETIAPINE FUMARATE	Camber Pharmaceuticals, Inc.	5c6aeb85-3ac2-4448-b544-9a4c5f562ed3	2024-04-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204316 application number: ANDA204316

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2S3PL1B6UJ	QUETIAPINE FUMARATE	111974-72-2	QUETIAPINE FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312743	QUEtiapine fumarate 100 MG Oral Tablet	PSN	070faf07-0ce7-4354-8643-9d222b72ecad	3
317174	QUEtiapine fumarate 200 MG Oral Tablet	PSN	070faf07-0ce7-4354-8643-9d222b72ecad	3
312744	QUEtiapine fumarate 25 MG Oral Tablet	PSN	070faf07-0ce7-4354-8643-9d222b72ecad	3
312745	QUEtiapine fumarate 300 MG Oral Tablet	PSN	070faf07-0ce7-4354-8643-9d222b72ecad	3
616483	QUEtiapine fumarate 400 MG Oral Tablet	PSN	070faf07-0ce7-4354-8643-9d222b72ecad	3
616487	QUEtiapine fumarate 50 MG Oral Tablet	PSN	070faf07-0ce7-4354-8643-9d222b72ecad	3
312743	quetiapine 100 MG Oral Tablet	SCD	070faf07-0ce7-4354-8643-9d222b72ecad	3
317174	quetiapine 200 MG Oral Tablet	SCD	070faf07-0ce7-4354-8643-9d222b72ecad	3
312744	quetiapine 25 MG Oral Tablet	SCD	070faf07-0ce7-4354-8643-9d222b72ecad	3
312745	quetiapine 300 MG Oral Tablet	SCD	070faf07-0ce7-4354-8643-9d222b72ecad	3
616483	quetiapine 400 MG Oral Tablet	SCD	070faf07-0ce7-4354-8643-9d222b72ecad	3
616487	quetiapine 50 MG Oral Tablet	SCD	070faf07-0ce7-4354-8643-9d222b72ecad	3
312743	quetiapine (as quetiapine fumarate) 100 MG Oral Tablet	SY	070faf07-0ce7-4354-8643-9d222b72ecad	3
317174	quetiapine (as quetiapine fumarate) 200 MG Oral Tablet	SY	070faf07-0ce7-4354-8643-9d222b72ecad	3
312744	quetiapine (as quetiapine fumarate) 25 MG Oral Tablet	SY	070faf07-0ce7-4354-8643-9d222b72ecad	3
312745	quetiapine (as quetiapine fumarate) 300 MG Oral Tablet	SY	070faf07-0ce7-4354-8643-9d222b72ecad	3
616483	quetiapine (as quetiapine fumarate) 400 MG Oral Tablet	SY	070faf07-0ce7-4354-8643-9d222b72ecad	3
616487	quetiapine (as quetiapine fumarate) 50 MG Oral Tablet	SY	070faf07-0ce7-4354-8643-9d222b72ecad	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72865-267-01	72865026701	100 TABLET, FILM COATED in 1 BOTTLE (72865-267-01)	2024-02-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quetiapine Fumarate	XLCare Pharmaceuticals Inc. \| Evaric Pharmaceuticals Inc	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	3